DB 2006(05) Managing Medical Devices

This document updates and replaces previous guidelines published in DB 9801 ‘Medical device and equipment management for hospital and community-based organisations’ (including supplement 1 'Checks and tests for newly-delivered medical devices'  and supplement 2 'Guidance on the sale, transfer of ownership and disposal of used medical devices') and also DB 2000(02) ‘Medical devices and equipment management: repair and maintenance provision’.

It is intended primarily for people in hospital and community based organisations (including social services) that are responsible for the management of medical devices, to help them set up systems that minimise risks associated with the use of those medical devices.

The purpose of this document is to outline a systematic approach to the purchasing, deployment, maintenance, repair and disposal of medical devices.

This guidance aims to:

• provide balanced information for groups developing local policy
• identify relevant legislation
• address the strategies for ownership and use of medical devices
• help healthcare organisations meet the Healthcare Commission’s core standards for the safe use of medical devices
• identify sources of additional guidance.

The main topics covered are:

• monitoring/audit
• reporting adverse incidents
• acquiring the most appropriate device
• acceptance procedures for newly delivered devices
• maintenance and repair
• training
• adequacy of manufacturer instructions
• prescribing the best device
• decontamination
• decommissioning
• disposal
• transfer of ownership
• legal liabilities
  

If you have enquiries about this publication please send an email to: dts@mhra.gsi.gov.uk or call us on 020 7084 3272.

Please note that there are no printed copies available.

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